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临床试验/NCT06564090
NCT06564090招募中不适用

Effect on Gait Pattern During Robot Assisted Gait Training (RAGT) of End-effector Type in Burn Patients

Hangang Sacred Heart Hospital2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2023年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
functional ambulatory category

研究概览

简要总结

This study aimed to investigate gait pattern and muscles power improvement of patient with gait disturbance caused by burns after end-effector type robot (Morning Walk®)-assited gait training (RAGT). This study randomly assigned 36 patients to one of two group : 30 minutes of Morning Walk® training with 30 minutes conventional physiotherapy (RAGT group) or 60 minutes of conventional physiotherapy (CON group). Five training sessions per week were given for 8 weeks. The primary outcomes were gait performance and muscles powers, which were assessed by the functional ambulation category (FAC) and the manual muscles test (MMT), respectively. The secondary outcomes included 6-minute walking test (6MWT), gait kinematic and spatiotemporal gait parameters. The results of this study is anticipated that the patients with gait disturbance receiving the RAGT might improve greater in gait performance and normal gait patterns that those trained with conventional physiotherapy.

详细描述

Patients with burn injuries to the lower extremities experience gait dysfunctions due to pain or joint contractures, and gait asymmetry occurs due to complications on the affected side. The persisting gait asymmetry placed these patients at risk for potential negative consequences, such as loss of bone mineral density of the affected side, overuse injury on the unaffected side due to compensatory actions, compromised postural control, and gait inefficiencies. Early gait training through physical therapy is a pivotal strategy for enhancing patients' quality of life, functional outcomes and mitigating burn-related complications. The conventional physical therapy is instrumental in fostering an increased range of motion (ROM) and mitigating contractures following burns or skin grafts. Physical therapy centers on patients' positioning, ROM, muscles strength, endurance, balance, coordination, and respiratory rehabilitation.Previous studies using end-effector type RAGT for patients with gait disturbances have demonstrated that RAGT combined with conventional physiotherapy could significantly improved walking speed, gait performance, and motor power . This study aimed to investigate gait pattern and muscles power improvement of patient with gait disturbance caused by burns after end-effector type robot (Morning Walk®)-assited gait training (RAGT).

This study randomly assigned 36 patients to one of two group : 30 minutes of Morning Walk® training with 30 minutes conventional physiotherapy (RAGT group) or 60 minutes of conventional physiotherapy (CON group). Five training sessions per week were given for 8 weeks. The primary outcomes were gait performance and muscles powers, which were assessed by the functional ambulation category (FAC) and the manual muscles test (MMT), respectively. The secondary outcomes included 6-minute walking test (6MWT), gait kinematic and spatiotemporal gait parameters. The results of this study is anticipated that the patients with gait disturbance receiving the RAGT might improve greater in gait performance and normal gait patterns that those trained with conventional physiotherapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Outcome measurements, and data analysis were performed by trained and blinded outcome assessor who was not involved in the intervention. The outcome measures were evaluated before training and immediately after 8 weeks of training.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who underwent split thickness skin graft (STSG) at Hangang Sacred Heart Hospital
  • with full or virtually full thickness involvement ( >50% of the body surface area of the lower extremity)
  • aged >18 years
  • with ≤ 1 functional ambulation category (FAC) score of ≤3 were included in this study.

排除标准

  • who had fourth-degree burns (involving muscles, tendons, and bone injuries)
  • severe communication disorders due to intellectual impairment and psychologic problems
  • body weight > 135kg or height >195cm
  • physical status that could limit physical therapy (severe deformity or contracture of limbs, open wounds, or pressure ulcers, severe osteoporosis).

结局指标

主要结局

functional ambulatory category

时间窗: 8 weeks

Ambulatory ability was rated by using the functional ambulatory category (FAC) scale.

次要结局

  • gait parameters(gait speed)(8 weeks)
  • gait parameters(cadence)(8 weeks)
  • 6 minute walking test(8 weeks)
  • gait parameters(step length)(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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